Kornimate/medical-research-clean huggingface dataset:
durvalumab with or without olaparib as maintenance therapy after first-line treatment of advanced and recurrent endometrial cancer

Conditions: Endometrial Neoplasms

Summary: a study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

this phase iii study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. target patient population: adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed stage iii, newly diagnosed stage iv, or recurrent endometrial cancer

Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of screening and female. * histologically confirmed diagnosis of epithelial endometrial carcinoma. all histologies, including carcinosarcomas, will be allowed. sarcomas will not be allowed. * patient must have endometrial cancer in one of the following categories: 1. newly diagnosed stage iii disease (measurable disease per recist 1.1 following surgery or diagnostic biopsy), 2. newly diagnosed stage iv disease (with or without disease following surgery or diagnostic biopsy) 3. recurrence of disease (measurable or non-measurable disease per recist 1.1) where the potential for cure by surgery alone or in combination is poor. * naïve to first line systemic anti-cancer treatment. for patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse * fppe tumor sample must be available for mmr evaluation. * has eastern cooperative oncology group (ecog) performance status of 0 or 1 within 7 days of starting study treatment. exclusion criteria: * history of leptomeningeal carcinomatosis. * brain metastases or spinal cord compression. * prior treatment with parp inhibitors. * any prior exposure to immune-mediated therapy, including (but not limited to) other anti ctla-4, anti-pd-1, anti-pd-l1, or anti-programmed-cell-death ligand 2 (anti-pd-l2) antibodies, excluding therapeutic anticancer vaccines.

Keywords: cancer of endometrium cancer of the endometrium carcinoma of endometrium endometrial cancer endometrial carcinoma endometrium cancer neoplasms, endometrial
evaluation of iprf with vit.d as an adjunct to non-surgical therapy in the treatment of stage iii periodontitis

Conditions: Periodontal Pocket

Summary: a clinical trial will be made to investigate the effect of locally applied injectable prf (iprf) plus vitamin d on the periodontal pockets in stage iii periodontitis patients

in this clinical trial, the treatment of periodontal pockets in stage iii periodontitis patients will be evaluated. the study participants will be divided in 3 groups: first group \>\> will be treated with professional mechanical plaque removal (pmpr) only. second group \>\> will be treated with pmpr + locally applied iprf. third group \>\> will be treated with pmpr + locally applied iprf + vitamin d. then the results will be compared after 6 months of the treatment (clinically and radiographically).

Eligibility criteria:
inclusion criteria: 1. patients with healthy systemic condition. 2. adult patients ˃ 18 years old. 3. patients with stage iii periodontitis. 4. patients accept 3-month follow-up period (cooperative patients). 5. patients provide an informed consent. exclusion criteria: 1. presence of prosthetic crowns. 2. extensive interproximal restorations. 3. periodontal therapy within the last 12 months. 4. having undergone surgical periodontal therapy or undergoing orthodontic treatment. 5. ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis. 6. the use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up. 7. smokers. 8. pregnant females.

Keywords: iprf vitamin d cholecalciferol periodontal pocket
the effect of tinnitus retraining therapy on subjective and objective measures of chronic tinnitus

Conditions: Tinnitus

Summary: the objective of this study is to examine the efficacy of tinnitus retraining therapy (trt) as a treatment of chronic tinnitus in people with limited hearing loss. the study design is prospective, randomized, double-blind, with repeated measures. the null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard trt and subjects treated with sham trt.

the specific aims of the study are to: * evaluate the efficacy of trt in reducing the objective magnitude of tinnitus. * evaluate the efficacy of trt in reducing the subjective awareness and impact of tinnitus. * determine the therapeutic time course of improvement in tinnitus. * determine the long-term improvement in tinnitus derived from trt.

Eligibility criteria:
inclusion criteria: * chronic non-pulsatile tinnitus exclusion criteria: * hyperacusis * subjective hearing loss * objective hearing loss with pure tone average greater than 35 db sound pressure level (spl) * evidence of significant depression or suicidal ideation

Keywords: tinnitus
role of a wheat containing diet on non-alcoholic steatohepatitis

Conditions: NASH - Nonalcoholic Steatohepatitis; Diabetes Mellitus, Type 2; Hyperlipidemias

Summary: effects of wheat-based diet vs. ati-free diet on nash

40 patients with the diagnosis of a non-alcoholic- steatohepatitis (nash) will be recruited at the university hospitals of mainz and frankfurt. patients are assessed with regards to their diet using standardized questionnaire and nutritionists. patients will be randomized into two parallel groups. the first group will continue a wheat-based nutrition, while the second group will receive dietary counselling to achieve an ati-free nutrition, trying to reduce the daily ati consumption. the clinical trial will run over 16 weeks including 4 visits at the study center. study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. in addition the patients have to complete dietary and health-related quality of life (hrql) questionnaires. visits are planned at baseline, w4, w8 and w16.

Eligibility criteria:
inclusion criteria: * histologically proven nash in the past 36 months with increased alt: males: \>60, females: \>42 u/ml * no body weight modification about \>10% in the past 24 weeks * no new drugs treating parts of the metabolic syndrome in the past 12 weeks * for patients with diabetes: hba1c value \<8,6% * the ability to understand the aim and the possible individual consequences of this trial * signed and dated consent before the trial starts exclusion criteria: * unstable coronary heart disease, stroke in the past 6 months * different liver diseases * proceeded fibrosis (fibroscan \>9,6 kpa) or histological cirrhosis * hepatocellular carcinoma or not curative treated carcinomas * alcohol consumption \>10g/day (females), \>20g/day (males) * gravidity * drugs causing secondary nash (e.g. tamoxifen, corticosteroids) * immunological or inflammatory diseases (e.g. systemic lupus erythematodes) * warfarin therapy * implementation of another special diet

Keywords: hepatic inflammation
efficacy and safety study of laparoscopic roux-en-y gastric bypass (lrygb) to treat type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus - Poor Control

Summary: type 2 diabetes mellitus (t2dm) resolution in morbidly obese patients following bariatric surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass index \[bmi\]\<35 kg/m2). many researches have shown available evidence about the efficacy and safety of metabolic surgery for resolution of t2dm in the non-morbidly obese. one of the most effective metabolic surgeries is laparoscopic roux-en-y gastric bypass (lrygb). the investigators intend to run a 3 year prospective multicenter study to evaluate the remission efficacy of laparoscopic roux-en-y gastric bypass in type 2 diabetes mellitus with low bmi (bmi:25-35) in asia area.

the study is designed including 9 bariatric centers across asia region( china, korea, phillipine, singapore and taiwan). totally 500 patients with confirmed diagnosis of t2dm and bmi between 25-35 kg/m2 will be enrolled from january 2011 to december 2013. preoperative surgical parameters, blood, biochemistry data, gastrointestinal hormones, upper gastrointestinal studies, abdominal ultrasound, peri-operative \& postoperative complications will all be recorded and analyzed. patient inclusion criteria: 1.) t2dm diagnosed over 1 year; 2.) age ranged 30-60 years; 3.) bmi 25-35 kg/m2; 4.) patient consent and will to receive long-term follow up and periodic check up. exclusion criteria: 1.) t1dm; 2.) substance abuse; 3.) planned pregnancy within 2 year after surgery; 3.) uncontrolled psychiatric disease; 4.) lost follow up. institutions inclusion criteria: professional experience over 30 lrygb performed. trial termination criteria: surgical mortality over 0.5% in the first year, and diabetes remission rate failure over 20% in one year. all data will be collected yearly in one center. the analysis of parameter, statistics and brief results will be informed to enrolled institutions periodically.

Eligibility criteria:
inclusion criteria: 1. t2dm diagnosed over 1 year; 2. age ranged 30-60 years; 3. bmi 25-35 kg/m2; 4. patient consent and will to receive long-term follow up and periodic check up. exclusion criteria: 1. t1dm; 2. substance abuse; 3. planned pregnancy within 2 year after surgery; 4. uncontrolled psychiatric disease; 5. lost follow up. institutions inclusion criteria: professional experience over 30 lrygb performed. trial termination criteria: surgical mortality over 0.5% in the first year, and diabetes remission rate failure over 20% in one year.
zenith® dissection endovascular system

Conditions: Aortic Dissection

Summary: the zenith® dissection clinical trial is a clinical trial approved by us fda to study the safety and effectiveness of the zenith® dissection endovascular system in the treatment of patients with aortic dissection.


Eligibility criteria:
inclusion criteria: * branch vessel obstruction/compromise * peri-aortic effusion/hematoma * resistant hypertension * persistent pain/symptoms * transaortic growth \>5 mm within 3 months * transaortic diameter \>40 mm. exclusion criteria: * age \<18 years; * other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years) * pregnant, breast-feeding, or planning on becoming pregnant within 24 months; * unwilling or unable to comply with the follow-up schedule * inability or refusal to give informed consent * simultaneously participating in another investigative device or drug study. (the patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) * additional medical restrictions as specified in the clinical investigation plan, or * additional anatomical restrictions as specified in the clinical investigation plan.

Keywords: aorta thoracic aortic dissection rupture type b debakey type iii endovascular
the outcomes of laparoscopic hybrid surgery versus totally open surgery

Conditions: Resectable Simultaneous Colorectal Cancer Liver Metastasis

Summary: simultaneous colorectal cancer liver metastasis (scrlm) is one of the risk factors for poor prognosis in colorectal cancer. surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable scrlm. simultaneous resection of colorectal cancer liver metastases by totally open surgery (tos) has been widely used. however, we propose that laparoscopic hybrid surgery (lhs) may have better short and long-term outcomes. this study aimed to compare the safety, short-term, and long-term efficacy of lhs versus tos for patients with resectable scrlms.


Eligibility criteria:
inclusion criteria: * liver metastasis was detected while the colorectal cancer was diagnosed. * both the primary lesions and liver metastases were confirmed by postoperative pathological examination. * clinical data is complete. exclusion criteria: * patients with unresectable extrahepatic metastases. * patients with other malignant tumor diseases that have not been cured. * clinical and pathological data were missed or incomplete follow-up data.
allogeneic epstein barr virus-specific cytotoxic t-lymphocytes in treating patients with progressive, relapsed, or refractory hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. donor white blood cells that are treated in the laboratory with epstein-barr virus may be effective treatment for hodgkin's lymphoma. purpose: phase i trial to study the effectiveness of allogeneic epstein-barr virus-specific cytotoxic t cells in treating patients who have progressive, relapsed, or refractory hodgkin's lymphoma.

objectives: * determine the toxicity of allogeneic epstein barr virus (ebv)-specific cytotoxic t-lymphocytes (ebv ctl) in patients with progressive, relapsed, or refractory ebv-positive hodgkin's lymphoma. * detect alterations in the anti-ebv cellular immunity of patients treated with ebv ctl. outline: donors undergo leukapheresis. epstein barr virus-specific cytotoxic t lymphocytes (ebv ctl) are cultured in vitro. patients receive an infusion of ebv ctl over 10 minutes on day 0. the ebv ctl infusion is preceded by 3 doses of fludarabine. patients then receive interleukin-2 injections for 12 days after the ebv ctl infusion. patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months. projected accrual: a total of 9 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven hodgkin's lymphoma * progressive, relapsed, or refractory disease after prior chemotherapy, radiotherapy, and/or stem cell transplantation * epstein barr virus (ebv) positive by immunohistochemical staining for lmp-1 or 2 or the presence of ebv rna (eber) * availability of an hla identical or haploidentical donor for cytotoxic t-lymphocytes, meeting the following criteria: * ebv seropositive * hiv negative * htlv-1 negative * hepatitis b surface antigen and hepatitis b core antibody igm negative * hepatitis c antibody negative * must share at least 1 hla haplotype with donor patient characteristics: age: * 18 to 75 performance status: * not specified life expectancy: * at least 8 weeks hematopoietic: * not specified hepatic: * bilirubin less than 2.0 mg/dl * sgot/sgpt less than 2.5 times normal (unless liver metastases are present) * if there is liver involvement by disease, an obvious relationship between sgot/sgpt and disease activity is required * no hepatic dysfunction causing moribundity renal: * creatinine clearance greater than 50 ml/min * no renal dysfunction causing moribundity cardiovascular: * no cardiac dysfunction causing moribundity pulmonary: * no pulmonary dysfunction causing moribundity other: * no neurologic dysfunction causing moribundity * no history of severe transfusion reactions with blood products (including fetal calf serum) * not pregnant prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics * no concurrent antimetabolites endocrine therapy: * not specified radiotherapy: * see disease characteristics surgery: * not specified

Keywords: recurrent adult hodgkin lymphoma
agent-797 in participants with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this is a phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agent-797, an unmodified, allogeneic inkt cell therapy, in participants with relapsed or refractory multiple myeloma, as well as to define the recommended phase 2 dose.


Eligibility criteria:
key inclusion criteria: 1. relapsed/refractory multiple myeloma 1. confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by international myeloma working group criteria and following prior therapy for multiple myeloma (mm) 2. relapsed or refractory mm requiring current treatment 3. previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-cd38 antibody agent 4. participants must have measurable disease as defined by at least 1 of the following: * serum m-protein ≥ 0.5 grams/deciliter (dl) by serum protein electrophoresis or for immunoglobulin a (iga) myeloma, by quantitative iga; or * urinary m-protein excretion at least 200 milligrams (mg)/24 hours; or * serum free light chain whereby the involved light chain measures ≥ 10 mg/dl and with an abnormal ratio 2. estimated life expectancy ≥ 3 months 3. no other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the principal investigator key exclusion criteria: 1. concurrent invasive malignancy 2. participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agent-797 3. prior radiotherapy within 2 weeks of start of study treatment 4. prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug

Keywords: multiple myeloma immunotherapy inkt cells
the sports-related injuries and illnesses in para-sport study (sriips)

Conditions: Athletic Injuries

Summary: the overall aim of this project is to gain an in-depth understanding of the epidemiology of sports-related injuries and illnesses in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.

the paralympic games is today one of the largest sport event in the world. during the last decades parasport has in many ways become elite sport, allowing people with disabilities to achieve extraordinary heights of functional capability. with the growing number of athletes there is an increased interest in athletes' health and safety, both to enhance sports performance and to prevent injuries. even though it is well-known that participation in sports places the athlete at risk for injuries, there are few studies covering sports-related injuries and illnesses in parasport (sriip). today, some injuries and illnesses are known to be preventable. however, this requires regular monitoring of internal and external load during athletic preparation. standardized injury surveillances have been implemented within several sports for abled-bodied athletes, but such studies do not yet exist within parasport. in our review article (fagher \& lexell 2014) the investigators showed that existing studies of sports-related injuries in athletes with disabilities have a variable quality and that specific disability related factors have not been examined. further studies are therefore warranted to obtain an increased in-depth knowledge of sriip. with a systematic longitudinal surveillance system tailored to parasport it would be possible to observe trends and risk factors over time, and thereby have a basis for developing specific preventive measures. the overall aim of this project is to gain an in-depth understanding of the epidemiology of sriip in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport. the specific aims are: i) to design and implement a study protocol for prospective epidemiological studies of sriip in parasport; ii) to prospectively estimate the annual incidence of sriip among swedish paralympic athletes; and iii) to explore risk factors and mechanisms for sustaining sriip based on athlete exposure in order to form the basis for moving towards safe participation in parasport.

Eligibility criteria:
inclusion criteria: * age 18-55 years * being a registered competitive athlete within the swedish paralympic program/organization * being able to communicate in swedish and having the opportunity to every week answer a web-based questionnaire.

Keywords: epidemiology sports medicine research protocol athletic injuries sports for persons with disabilities
lower-cost contingency management in a group setting - 1

Conditions: Substance Abuse

Summary: the purpose of this study is to evaluate the efficacy of prize contingency management (cm) in enhancing attendance, reducing drug use, and improving health among clients attending two hiv drop-in centers. specifically, 172 clients are randomly assigned to one of two 6-month treatment conditions: standard 12-step oriented group treatment, or cm group treatment. in the cm group, clients earn the chance to win prizes for submitting clean urine specimens and for complying with steps toward their treatment goals. activities related to improving health will be emphasized, such as attending medical appointments, recording daily medication consumption, getting prescriptions filled, and attending medication adherence support groups. group attendance, drug use, medical problems, services received, and risky drug use and sexual behaviors will be measured pre-treatment and at months 1, 3, 6, 9 and 12.


Eligibility criteria:
inclusion criteria: * hiv-positive and a member of the living center or the manchester area network on aids * dsm-iv diagnosis of current opioid or cocaine abuse or dependence * willingness to accept random assignment to one of the two treatment groups exclusion criteria: * inability to comprehend the study (mini-mental status score \<21; folstein \& folstein, 1975; or inability to pass an informed consent quiz) * severely disruptive behavior * in recovery for pathological gambling (due to potential similarity between the cm procedure and gambling) * non-english speaking

Keywords: contingency management substance abuse